Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Related Clinical Trial
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels Comprehensive Long-term Follow up of Adults With Arterial Switch Operation Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease Canadian Adult Congenital Heart Disease Intervention Registry Physical Training in Transposition of the Great Arteries Eplerenone in Systemic Right Ventricle N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) Genetic Determinants of Congenital Heart Disease Outcomes Myocardial Contrast Echocardiography in Congenital Heart Disease Sudden Cardiac Death in Systemic Right Ventricle Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease Comparison of Hematocrit Levels in Infant Heart Surgery Late Function After Surgery for Transposition of the Great Arteries Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA) MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries Fibrosis, Valvular and Ventricular Function in Patients With TGA Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults Nitric Oxide During Bypass for Arterial Switch Operation

Brief Title

Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Official Title

Clinical Impact of Rapid Prototyping 3D Models of Congenital Heart Disease on Surgical Management

Brief Summary

      Patient-specific, 3D printed models have been utilized in preoperative planning for many
      years. Among researchers and clinicians, there is a perception that preoperative exposure to
      3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D
      printed models for heart surgery have the potential to improve a clinician's preparedness and
      therefore may reduce surgically-related morbidity and mortality. This randomized clinical
      trial aims to evaluate whether pre-procedural planning of surgeons exposed to a
      patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity,
      and mortality.
    

Detailed Description

      3D imaging and rapid prototyping 3D printing technology have advanced to the point where it
      is feasible to marry the two to produce a patient-matched and accurate 3D model of congenital
      heart defects. The production of a 3D model of the heart may be particularly useful in
      anticipation of surgery such that the operator can plan and visualize the surgery prior to
      the surgical date with a physical heart he or she can manipulate in their hands.

      Preliminary studies demonstrate potential for clinical impact of 3D models on patient care
      and patient outcomes. 3D models have long been shown to enhance education and communication
      of anatomy. In 2008 Kim et al reviewed 3D printed models as an emerging technology in
      management of congenital heart disease, and also suggests that physical models may also help
      enhance patients and physicians' understanding of congenital heart disease. Our group has
      also published on the clinical and educational value of these 3D heart models. To date, no
      systematic trial identifying the value of 3D models on procedural planning has been
      published.
    


Study Type

Interventional


Primary Outcome

Time under cardiopulmonary bypass

Secondary Outcome

 Mortality

Condition

Double Outlet Right Ventricle

Intervention

3D Printed Heart Model

Study Arms / Comparison Groups

 Control
Description:  Standard of care (not involving 3D printing)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

0

Start Date

May 1, 2017

Completion Date

June 2021

Primary Completion Date

April 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart
             defect, including but not limited to:

               1. double outlet right ventricle (DORV),

               2. transposition of the great arteries with ventricular septal defect and pulmonary
                  stenosis (TGA/VSD/PS),

               3. truncus arteriosus with ventricular septal defect (TA/VSD)

               4. congenitally corrected transposition of the arteries with pulmonary stenosis
                  (CCTGA/PS).

          -  Patient who will undergo preoperative cardiac MR or cardiac CT imaging

             a. Images will be validated by the IRC prior to inclusion

          -  Written informed consent (and assent when applicable) and HIPAA authorization obtained
             from subject or subject's legal representative and ability for subject to comply with
             the requirements of the study.

        Exclusion Criteria:

          -  Complex defects involving atrioventricular valve anomalies

               1. complete or transitional atrioventricular canal

               2. double inlet left ventricle

               3. tricuspid atresia

               4. mitral atresia

          -  Defects with valve dysfunction requiring an extensive valvuloplasty

          -  Patients with a contraindication to MRI scanning will be excluded unless they are
             referred for a cardiac CT per clinical standard of practice. These contraindications
             include patients with the following devices:

               1. Central nervous system aneurysm clips

               2. Implanted neural stimulator

               3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR
                  conditional according to the manufacturer

               4. Cochlear implant

               5. Ocular foreign body (e.g. metal shavings)

               6. Implanted Insulin pump

               7. Metal shrapnel or bullet.

               8. Any contraindications to receiving IV gadolinium contrast, determined clinically

          -  Subjects where MRI or CT images are acquired more than six months prior to the
             scheduled surgical date

          -  Subjects where date of scan to date of surgery is less than 10 calendar days

          -  Subjects where MRI or CT reconstruction is limited due to poor image acquisition as
             solely determined by the Image Reconstruction Center.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Laura Olivieri, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04788082

Organization ID

15-090


Responsible Party

Principal Investigator

Study Sponsor

Children's National Research Institute

Collaborators

 Phoenix Children's Hospital

Study Sponsor

Laura Olivieri, MD, Principal Investigator, Children's National Research Institute


Verification Date

March 2021